Infection Prevention for "Bellwether" Surgery in Ethiopia

NCT07647796 | Not Yet Recruiting

• 1 other identifier: AMR Ethiopia
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study examines surgical site infections and antimicrobial resistance following life-saving surgeries like C-sections and leg fracture repairs in Ethiopia. It does not include healthy volunteers because it specifically focuses on patients who require these urgent operations due to medical necessity. Eligible participants are those undergoing these specific procedures at Tikur Anbessa Specialized Hospital or other participating public hospitals. While the birth-related portion is for females, the trauma portion includes both men and women, generally of reproductive or working age with no upper age limit. People are excluded if they are having elective surgeries, cannot provide consent, or cannot be reached for the two-year follow-up period. The researchers use a mixed intervention based on the "Clean Cut" safety bundle, which includes staff training, surgical checklists, and regular audits. The main goals are to measure infection rates within 30 days of surgery and track how well patients can function in their daily lives using the WHODAS scale up to 24 months later.

Conditions

Ceserean Section; Lower Limb Fractures; Surgical Site Infection (SSI)

Keywords

Surgical Site Infections; Global Surgery; Ethiopia; Multidrug resistance; Antimicrobial resistance; Subsahara Africa

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection (SSI)

  The rate of surgical site infections diagnosed post-operatively.

  Up to 30 days post-surgery

Secondary Outcomes (1)

• Long-term Functional Health Status Assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Up to 24 months post-surgery

Study Arms (1)

Lower Limb Fractures

Other: Surgical Site Infection Prevention and Control (IPC) Bundle

Interventions

Surgical Site Infection Prevention and Control (IPC) Bundle OTHER

This intervention is a multi-modal infection prevention and control (IPC) bundle adapted from the Clean Cut program specifically for emergency "Bellwether" surgeries, including Caesarean sections and open limb fractures, within the Ethiopian public health system. The bundle incorporates routine sterilization audits and the establishment of structured feedback loops to improve perioperative routines and ensure high adherence to hygiene protocols. Furthermore, this intervention is specifically evaluated for its impact on both short-term infection rates and long-term functional recovery, integrating clinical outcomes with antimicrobial resistance (AMR) surveillance.

Lower Limb Fractures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises Ethiopian patients requiring emergency "Bellwether" surgeries at Tikur Anbessa Specialized Hospital and participating public facilities. Specifically, the cohort includes women undergoing Caesarean sections and individuals of both sexes presenting with open tibia or femur fractures. The population represents adult clinical cases requiring urgent surgical intervention, excluding healthy volunteers and elective procedures.

You may qualify if:

• Emergency Caesarean section.
• Open tibia/femur fractures.
• Treated at participating Ethiopian hospitals.

You may not qualify if:

• Elective or non-bellwether surgeries.
• Inability to provide informed consent.
• Lost to follow-up for 24-month assessment.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Tikkur Anbessa

Addis Ababa, Ethiopia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Culture swaps from surgical sites will be taken. Growth on agar plates and from these cultures the DNA will be extracted for sequencing.

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Helen Sinabulya, Md, PhD

CONTACT

+46705666670; helen.sinabulya@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From the start of data collection and until the results are published.

Locations

ET (1)